Cl II NeuViz 64 Multi-Slice CT Scanner

Company: Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 5/18/2016
Class lI:

PRODUCT

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Recall Number Z-1650-2016

REASON
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn’t meet the patient position description, when the scanner position was set to “Right” in the system setting – scanner options.

RECALLING FIRM/MANUFACTURER
Neusoft Medical Systems Co., Ltd. , Shenyang China on 5/2/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
US Distribution – Including Puerto Rico and the states of IL, CT, SC, NE

___________________________________

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.